AccessGUDID - DEVICE: Vagisil Prohydrate Natural Feel Internal Vaginal Moisturizing Gel (00011509060501)

GUDID

Device Identifier (DI) Information

Brand Name: Vagisil Prohydrate Natural Feel Internal Vaginal Moisturizing Gel
Version or Model: Item Code: 6050
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Item Code: 6050
Company Name: COMBE PRODUCTS, INC.

Primary DI Number: 00011509060501
Issuing Agency: GS1
Commercial Distribution End Date: October 11, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 091123992 *Terms of Use

Device Description: Vagisil Moisturizing Gel is an Over-The-Counter personal lubricant, intended to both moisturize and lubricate and is presented in 8 pre filled applicators of 0.20 oz (5.9 g) each for easy use. The device is sold in a carton. REFERENCE FDA UDI ALTERNATIVE NUMBER: UDI-A160001

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60412	Sexual lubricant	A substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUC	Lubricant, Personal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 101b7aa5-d843-485f-93c6-af74f37982e7
Public Version Date: October 12, 2023
Public Version Number: 5
DI Record Publish Date: September 26, 2016